Cleared Traditional

K884032 - MORGAN TRANSCUTANEOUS ELECTRICAL NERVE ...

K884032 is the FDA 510(k) clearance for MORGAN TRANSCUTANEOUS ELECTRICAL NERVE ... by Morgan Associates, Inc.. It is a Class 2 Neurology device (product code GZJ) cleared through the Traditional 510(k) pathway after a 20-day FDA review.

K884032 · Morgan Associates, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1988
Decision
20d
Days
Class 2
Risk

K884032 is an FDA 510(k) clearance for the MORGAN TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR. Classified as Stimulator, Nerve, Transcutaneous, For Pain Relief (product code GZJ), Class II - Special Controls.

Submitted by Morgan Associates, Inc. (New York, US). The FDA issued a Cleared decision on October 13, 1988 after a review of 20 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5890 - the FDA neurology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Morgan Associates, Inc. devices

Submission Details

510(k) Number K884032 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 23, 1988
Decision Date October 13, 1988
Days to Decision 20 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
128d faster than avg
Panel avg: 148d · This submission: 20d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5890
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Neurology devices follow this clearance model.

Regulatory Peers - GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief

All 49
Devices cleared under the same product code (GZJ) and FDA review panel - the closest regulatory comparables to K884032.
MEDTRONIC MODEL 90002065 MF TENS SYSTEM
K911963 · Medtronic Vascular · Dec 1991
DYNEX IIIB, MODEL 89002026
K913594 · Medtronic Vascular · Aug 1991
TENZCARE STIMULATOR 6890
K891992 · 3M Company · Oct 1989
MEDTENS(TM), MODEL NUMBER 7725
K871722 · Medtronic Vascular · Jul 1987
ECLIPSE+, MODEL NUMBER 7723
K865048 · Medtronic Vascular · Feb 1987
CODETRON TRANSCUTANEOUS ELECTRICAL NERVE STIMULA.
K863469 · Cordis Corp. · Feb 1987